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A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects

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ClinicalTrials.gov Identifier: NCT00856687
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : January 22, 2010
Sponsor:
Information provided by:
Pfizer

Brief Summary:
PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.

Condition or disease Intervention/treatment Phase
Asthma Drug: PF-03893787 Drug: Placebo Drug: Montelukast Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Arm Intervention/treatment
Experimental: PF-03893787 Drug: PF-03893787
Oral, two doses 12 hours apart

Placebo Comparator: Placebo Drug: Placebo
Oral, two doses 12 hours apart

Active Comparator: Montelukast Drug: Montelukast
Oral, two doses 12 hours apart




Primary Outcome Measures :
  1. Spirometry pre- and post- bronchial allergen challenge [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Laboratory safety tests [ Time Frame: 2 months ]
  2. 12-lead ECGs [ Time Frame: 2 months ]
  3. Adverse Event reporting [ Time Frame: 2 months ]
  4. Blood samples for pharmacokinetic measurement [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18-60 years.
  • Mild asthma
  • Atopic to allergens

Exclusion Criteria:

  • Unstable asthma.
  • Smokers or recent ex-smokers
  • Recent allergen challenge

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856687


Locations
United Kingdom
Pfizer Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00856687     History of Changes
Other Study ID Numbers: B0281002
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010

Keywords provided by Pfizer:
Asthma Allergen Challenge

Additional relevant MeSH terms:
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action